Celadrin

Product NDC: 54230-356
11-digit product format: 542300356
Labeler code: 54230
Product ID: 54230-356_097fcff2-ea99-0878-e063-6394a90aa0fd
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Factors Group of Nutritional Products
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-10-01
Substance: MENTHOL
Active strength: 12.5 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54230-356-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54230-356-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54230-356-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54230-356-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54230-356-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54230-356-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54230-356-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Celadrin
Brand name suffix: Joint and Muscle Pain Relieving
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	12.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416982	Internal RxNorm lookup
1046429	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6396e4b6-2130-433b-bdb3-97c76dbe685c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54230-356-01	2023-03-30	C162847	48780-1	9d75b9d1-1749-f424-e053-dadaa90a57ce	Factors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)
54230-356-01	2020-01-31	C162847	48780-1	9d75b9d1-1749-f424-e053-dadaa90a57ce	Factors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54230-356-01	CeladrinJoint and Muscle Pain Relieving	170 g in 1 JAR	CREAM	170		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54230-356	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	3	Current NDC, Legacy NDC, 1 package rows	20231107_6396e4b6-2130-433b-bdb3-97c76dbe685c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 122 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAIN RELIEF PATCHES	LIDOCAINE	Walgreen Company	1a587e6e-88d1-4b01-abad-9a365dc64a4d	2024-10-15	Warnings	Exact identifier application number: M017
TopCare Everyday After Sun Cooling	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	baff7293-e1a3-d1f2-e053-2995a90a93ca	2024-10-15	Warnings	Exact identifier application number: M017
Universal PAIN RELIEF	LIDOCAINE	Universal Distribution Center LLC	b132a4f2-1b1f-4e80-a183-f9add449065f	2024-10-14	Warnings	Exact identifier application number: M017
Nervex Pain Relieving	CAPSAICIN	VITA SCIENCES, LLC	a39bba22-8c54-4252-9973-052dd2aaea36	2024-10-14	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	NATURAL ESSENTIALS, INC.	d07fdffd-bf7c-4950-9b2d-c06d54ef4c55	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Cooling	LIDOCAINE HYDROCHLORIDE	WALGREEN COMPANY	baffb272-436c-4ad8-e053-2a95a90a56fb	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Sunburn Relief	MENTHOL	WALGREEN COMPANY	c8967fba-6c28-494b-e053-2995a90acbba	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Sunburn Relief	LIDOCAINE	WALGREEN COMPANY	d5067903-c559-dc6d-e053-2995a90a8ee3	2024-10-14	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF	Meijer Distribution Inc	18998e1c-1254-4d0c-93f1-26652c5ca076	2024-10-14	Warnings	Exact identifier application number: M017
signature care itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Safeway	3eedcd9f-8312-4d14-a0fe-6b00a00d3e73	2024-10-13	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	H E B	34c7bcd3-203f-4630-894d-3739a1576c8d	2024-10-13	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	25ec9014-64c4-44df-9e67-9f9223ffc923	2024-10-12	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	LIDOCAINE AND MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f02fa9c0-b8af-f362-e053-2a95a90ae516	2024-10-11	Warnings	Exact identifier application number: M017
Insect Sting Relief Pad	BENZOCAINE, ALCOHOL	Hubei Changjian Medical Products Co., Ltd.	6a269982-0e25-4c09-aef1-0b398bdc5ed4	2024-10-11	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	24221805-e5c9-5785-e063-6394a90a9d2f	2024-10-10	Warnings	Exact identifier application number: M017
De La Cruz Camphor	CAMPHOR	DLC Laboratories, Inc.	62359237-de2d-4497-bfd6-36991cfc8acf	2024-10-10	Warnings	Exact identifier application number: M017
Anti Itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Meijer Distribution Inc	4f536a86-6419-4ab0-a7e8-5c37943823e2	2024-10-09	Warnings	Exact identifier application number: M017
terrasil Bruise and Pain Relief Maximum Strength	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	240b231d-a8b2-c64c-e063-6394a90a7440	2024-10-09	Warnings	Exact identifier application number: M017
Muscle Freeze Relief	MENTHOL	NATURAL ESSENTIALS, INC.	815c534b-096d-49f2-b5f2-8c885d45a5e6	2024-10-09	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046429	Celadrin 1.25 % Topical Cream	PSN	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
416982	menthol 1.25 % Topical Cream	PSN	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	menthol 12.5 MG/ML Topical Cream [Celadrin]	SBD	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
416982	menthol 12.5 MG/ML Topical Cream	SCD	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	Celadrin 1.25 % Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	Celadrin 12.5 MG/ML Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	Celadrin Cream 12.5 MG/ML Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
416982	menthol 1.25 % Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
54230-356-01	54230035601	170 g in 1 JAR (54230-356-01)	170 g	2012-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Factors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)	Factors Group of Nutritional Products	2023-11-06	HUMAN OTC DRUG LABEL	3